Cook Medical, of Bloomington, Indiana, has announced the recall of Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters because of complaints that the catheter tip may split or separate from the catheter.
If the tip does separate, the tip could enter the patient’s bloodstream, and could cause serious injury or even death to the patient and could require additional medical intervention to retrieve the tip. According to the recall notice, tip splitting or separation may also cause the device to stop working. The recall notice with the complete list of affected lot numbers can be found on the Food and Drug Administration (FDA) web site.
Cook Medical has received 26 reports of the device malfunctioning, with 14 of these malfunctions resulting in reports of adverse events. This recall has been designated Class 1. A Class 1 recall—the FDA’s most serious type of recall—involves a situation in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram, a type of X-ray used to diagnose heart conditions (cardiac angiogram). The catheter is inserted into the body through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye.
The recalled catheters were manufactured from May 9, 2013 to September 1, 2014 and were distributed from June 6, 2013 to June 25, 2015, according to the FDA. Nearly 39,000 catheters were recalled in the United States.
On July 2, 2015, Cook Medical sent customers an Urgent Medical Device Recall letter. The letter instructed customers to immediately quarantine unused catheters from their inventory and collect and return all unused products to Cook Medical as soon as possible. Customers can contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235, Monday through Friday from 7:30 a.m. to 5:00 p.m., Eastern Time.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these catheters to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/medwatch/report.htm.